New System Reduces Administrative Barriers in Executing Research

A whole slew of obstacles can keep a new discovery from making its way into the medicine cabinet: the science is difficult, the funding is scarce and the regulatory paperwork involved can take critical time away from the research itself.

Now a new online tool -- created by the North Carolina Translational and Clinical Sciences Institute (NC TraCS) in partnership with the UNC Office of Research and Information Systems (ORIS) -- helps the clinical research coordinators, physicians and staff who conduct clinical research tackle the last of these obstacles more easily. On Friday, December 2, staff from NC TraCS presented the tool – called the Clinical Research Management System (CRMS) -- to a packed crowd in the Bioinformatics Auditorium on the campus of UNC-Chapel Hill.

Around 100 potential users of the new system attended a “Lunch ‘n’ Launch” that showcased a number of its best attributes, such as easy electronic regulatory submissions, a virtual “dashboard” to track study progress, better budget building tools and enhanced feasibility testing.

Michelle Maclay, NC TraCS communications specialist, kicked off the event by giving the attendees a quick overview of NC TraCS, UNC’s home of the NIH Clinical and Translational Science Awards (CTSA). As she explained, the CTSA consortium encompasses 60 institutions, linking them together to energize the discipline of clinical and translational science.

One way NC TraCS is catalyzing this new science is by assisting clinical research coordinators such as Michelle Duclos, M.P.H., who serves on the steering committee of the UNC Network for Clinical Research Professionals (UNC-NCRP). Duclos spoke about how UNC-NCRP serves as a forum to increase awareness and communication of best practices through a series of educational seminars, resources, mentoring and networking programs.

“We want all clinical research coordinators to join the conversation, because this forum is only as good as all of you make it to be,” stated Duclos. “This group is a great way to facilitate the spread of knowledge about clinical research. It is important that we do our jobs safer, faster and with better outcomes for our patients.”

Ed Finerty, project manager for the CRMS, said that he and his team created the new database to specifically address administrative barriers in executing research. In doing so, they gathered vital input from an alphabet soup of regulatory campus offices like IDS [Investigational Drug Services], OCT [Office of Clinical Trials] and IRB [Institutional Review Board]. Finerty presented the audience with a fast tour through the application, going over a number of the tools that he viewed as being most in demand.

“For example, we saw that there were lots of forms, asking for the same information over and over again – so we put them all online and integrated them, such that data saved in one form auto-populates other forms,” explained Finerty. “Also, we noticed a lack of visibility in the submission process – so we created a study dashboard that enables users to visually track whether their submissions are in the IDS , OCT and so on. It is so simple to track – items on the dashboard start out gray, turn yellow when you have to do something about them, and then turn green when you are done.”

The audience was clearly impressed by the potential impact of the new application and broke into applause at several points during Finerty’s demonstration. As he described it, the CRMS can be a place to test out planned studies, allowing researchers to figure out from the beginning how much various parts of the process will cost so they can obtain the funding needed to complete their studies.

Finally, Finerty emphasized that the CRMS is a UNC-built application, meaning that its “capabilities will grow to include the entire study life cycle.” CRMS 1.0 addressed budget building and feasibility. The most recent version, CRMS 2.0 added online submissions and revised budget tools. Up next is CRMS 3.0, which will include an integrated Clinical and Translational Research Center (CTRC) scheduler, financial monitoring and a pre-populated IRB application.

“I feel like all the paperwork has been the bane of my existence for the 22 years I have been in research,” joked attendee Susan Jones, a clinical research coordinator at UNC. “No matter how many times I’ve filled those forms out, it seems I always forget something and have to go back to an office to fill in more information. Let’s just say I’ve really been looking forward to this.”

For others who have been looking forward to the launch of the CRMS, NC TraCS is offering training sessions on the new system in Brinkhous-Bullitt on December 7, December 14, January 6 and January 13.